The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0474-2015·Announced 2014-11-19

Maine Natural Health Recalls Pure Whey Vanilla Protein Supplement for Undeclared Milk

Maine Natural Health, Inc. is recalling Pure Whey Vanilla dietary supplements because the packaging fails to declare the allergen milk.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Protein supplement fails to declare allergen: milk"

Plain-English summary

Maine Natural Health, Inc. is recalling Pure Whey Vanilla dietary supplements packaged in 2 lb (32 oz), 10 oz, and 30 gram sizes. The product is packaged under the labels Maine Natural Health and Stronger Faster Healthier. The recall is being conducted because the product fails to declare the allergen milk on the label.

The recall covers 24,742 units of the product. The distribution pattern is nationwide. All lot codes are affected because the label fails to declare the allergen milk.

Consumers with this product should stop using it and contact the recalling firm for instructions on how to dispose of or return the product.

The recalled product

Product
Pure Whey Vanilla , Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
Affected units
24,742

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots codes that the label fails to declare the allergen milk

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Maine Natural Health, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

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